Please can you give an introduction to the Trans-Pacific Partnership (TPP) Agreement? Which countries are in negotiation?

The Trans-Pacific Partnership (TPP) is a trade deal currently being negotiated between eleven countries of the Asia-Pacific region: Australia, Brunei Darussalam, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, United States, Singapore and Vietnam.

But the scope of the TPP is potentially much broader than the current eleven countries. Negotiators have said that they are structuring the agreement in such a way that would allow more countries to join, and the TPP could eventually include all twenty-one APEC nations. Thailand has already announced its intention to join, and Japan and the Philippines are actively considering it.

Even more alarming, U.S. negotiators have said the TPP will be the template for future U.S. trade agreements across the globe, setting a damaging precedent that could affect many more developing countries.

The TPP negotiations are being conducted in secret but leaked texts reveal the most aggressive intellectual property (IP) measures ever suggested in a trade deal with developing countries. The U.S. proposals threaten to roll back internationally-agreed public health safeguards and would put in place far-reaching monopoly protections that keep medicine prices high and out of the reach of millions.

What are the aims of the TPP Agreement?

TPP government officials describe the TPP as a vehicle for greater economic integration in the Asia Pacific region. The TPP represents a departure from more traditional trade agreements in that it reaches further into “behind-the-border” domestic regulation and aims to impose stronger regulatory coherence, intellectual property rights and investor protections.

MSF and many public interest groups are concerned that the far-reaching and precedent-setting terms being proposed will severely limit the ability of governments to legislate and regulate in the interest of public health.

Why are the TPP negotiations being conducted in secret?

This is a question that MSF and many others have been asking – including many members of Congress in the United States – and as far as MSF is concerned, there has been no satisfactory response.

The TPP negotiators are making decisions that will affect at least 600 million people, and potentially hundreds of millions more, in complete secrecy, and this is unacceptable. It is unfortunate that MSF and others are forced to rely on leaked copies of an agreement that could have dire health consequences for millions of people.

MSF is advocating for greater transparency that will allow for adequate public scrutiny and debate before it is too late to affect the outcome of the agreement. We know that trade negotiations can be, and have been, conducted in a more transparent manner in the past, for example under the auspices of the WTO. MSF is urging TPP negotiators to publish the draft agreement and their negotiating positions, particularly as it relates to matters affecting public health, so these vitally important issues can be openly debated by those who will be directly affected.

Please can you tell us about the leaked texts regarding the TPP Agreement? What did these texts reveal?

According to the leaked text that we have seen the proposed IP rules would grant the pharmaceutical industry a wide-ranging set of legal mechanisms designed to prolong monopoly protection for medicines and delay the availability of more affordable generic versions.

This week we have released a new four-page TPP briefing that summarizes some of our concerns. For example, one proposed TPP provision would require governments to grant new 20-year patents for modifications of existing medicines, such as a new forms, uses or methods, even without improvement of therapeutic efficacy for patients. Another provision would make it more expensive and cumbersome to challenge undeserved or invalid patents; and yet another would add additional years to a patent term to compensate for administrative processes. Taken together, these and other provisions will add up to more years of high-priced medicines at the expense of people needing treatment waiting longer for access to affordable generics.

The TPP proposal in the investment chapter also includes investor-state investment dispute provisions that would allow corporations to file suit against governments using private tribunals if they perceived that a particular regulation negatively affected their anticipated profits. In the case of access to medicines, intellectual property is explicitly mentioned as covered by the investment chapter and therefore pharmaceutical firms could use TPP investor-state dispute provisions to overturn national patent (and other IP) laws that may be designed to protect public health. This is in fact already happening in Canada, where Eli Lilly is threatening to sue the government of Canada under similar rules included under NAFTA because Canada rejected a drug patent considering it did not adequately meet the criteria for patentability.

If the agreement was to finally include the US proposals as they currently stand, we believe it will be the most harmful trade deal ever for access to medicines in developing countries. These demands represent a complete repudiation of previous global health commitments, including the 2001 WTO Doha Declaration on TRIPS and Public Health and the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property. The U.S. is walking away from its own 2007 bipartisan trade policy, which promised to scale back some of the harshest IP provisions in trade deals with developing countries.

What concerns do Médecins Sans Frontières have over the TPP Agreement?

As a medical humanitarian organization working in more than 70 countries, MSF is concerned that if the TPP terms are imposed on developing countries, competition from price-lowering generic medicines that are so vital to the viability of our programs, and to the health of the people we treat, will be severely restricted.

As a medical treatment provider, MSF relies on affordable, quality generic medicines to treat many diseases, including tuberculosis, malaria, HIV/AIDS and other infections that afflict the poorest and most vulnerable populations. For example, MSF relies on affordable quality generic medicines for its programs in Myanmar and in Cambodia. We can access affordable medicines thanks to public health safeguards that enable competition, which brings down prices of medicines and allows more lives to be saved.

Many developing countries have implemented safeguards in their national patent laws to promote competition; India, the pharmacy of the developing world, is a prominent example. But the U.S. is demanding that TPP countries accept provisions that would grant pharmaceutical firms extended and stronger monopoly protections on high-priced medicines, keeping affordable generics out of the market for longer. If the US gets its way, TPP countries will not be allowed to implement many of these key legal safeguards, what will mean drugs priced out of reach for longer. And because the TPP is what the U.S. intends as the new norm, this would then become entrenched as a baseline in new trade agreements in the future, potentially sweeping up many more developing countries struggling to improve access to medicines for millions in need.

But it is not only MSF that will be affected. Major international treatment initiatives and agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program and UNITAID, also depend heavily on affordable generic drugs to scale up urgently needed treatment programs. For example, more than 98% of the antiretroviral medicines purchased by PEPFAR to treat HIV/AIDS are low-priced, quality-assured generic medicines.

Governments that pay for treatment programs, either directly or by funding global health treatment initiatives, have both an interest and a responsibility to ensure that new roadblocks are not put in the way of generic competition, or they risk jeopardizing the effectiveness of the very programs they support.

How many people in developing countries currently don’t have access to the medicines they need?

It is difficult to measure, but the World Health Organization estimates that at least two billion people have no regular access to medicines. (1) There are many reasons why patients still lack regular access to affordable medicines, but the high price of existing medicines or the fact that they do not exist because they are not seen as financially viable are two important causes.

Many people still die from diseases like AIDS, TB and other diseases that disproportionally affect poor people in developing countries due to the high prices of medicines. But the burden of disease in developing countries is changing and non-communicable diseases (NCDs) such as diabetes, cardiovascular disease, and cancers, are now also a leading cause of death in developing countries.

Prices for newer medicines – including second-line HIV drugs and treatments for hepatitis, tuberculosis, cancer and many other diseases – are climbing rapidly and can cost hundreds of times more than a person’s average annual income posing a life treating access barrier to increasing numbers of people.

What impact do you think a lack of vital medicines will have on the spread of diseases such as HIV/AIDS?

The story of access to HIV medicines is a great illustration of the overall problem. Between 1990 and 2000, explosive growth of the HIV/AIDS epidemic in developing countries, especially in Africa, was characterized with a devastating lack of access to life-saving antiretroviral treatments that were, by then, broadly accessible in developed countries. In 2000, ARVs were priced at more than $10,000 per patient per year -- out of reach of the vast majority of people living in developing countries.

But international pressure forced multinational pharmaceutical firms to make groundbreaking concessions, triggering generic competition and massive ARV price reductions that brought the price of treatment down by 99 per cent, from over US$10,000 per person per year a just over decade ago, to just $120 today. These prices have made it possible for eight million people in developing countries to be on treatment today and for international organisations like the Global Fund to Fight AIDS, Tuberculosis and Malaria and PEPFAR (the U.S. government-backed HIV initiative) to reach many more people.

But, half of those in need of HIV/AIDS treatment are still not receiving it. Furthermore, many HIV patients we treat now have to move to second and third line treatment as they develop resistance to first line regimes. Sadly, patents now exist on most new and second-line drugs, allowing pharmaceutical companies to restrict competition and price them out of reach for many. As a result these drugs – which are far better and have fewer adverse side effects – are only available in countries that have the capacity to cover the high cost. Poor patients are forced to wait until the patents expire or prices are brought down through international advocacy efforts.

How do you think access to medicines in developing countries should be improved?

Lowering the price of health commodities is essential for developing countries. The lack of access to medicines – and other health commodities – can be attributed to multiple factors, but one of the most fundamental barriers is high prices.

The most effective and sustainable way to bring down the price of a drug is through competition between different manufacturers. Developing country governments need to have the flexibility to design patent laws and other health-related regulations in a way that meets the health needs of their populations, and in most cases this is by enabling access to generic medicines.

Another major factor limiting access is that the medicines and other health innovations that people in developing countries need are often simply not developed. This is because medical innovation - the development of new drugs, diagnostics and vaccines - is overwhelmingly steered towards products that will give commercial rewards and not towards the greatest medical needs.

In the current predominant medical innovation model, companies recoup research and development (R&D) investments through sales revenues, so its R&D costs are inevitably “linked” to product prices. This means that development of products needed primarily by populations unable to pay high prices is simply not pursued.

There is a need to develop alternative strategies for medical innovation that respond to developing country priorities and that break the link between the cost of research and the price of the final product. This ‘delinkage’ ensures affordability of medical innovation from the outset.

We think the TPP countries could construct a much better trade agenda that promotes both innovation and access to medicines if they were to encourage innovative incentive mechanisms that better respond to patient-needs, instead of monopolies and policies that break the balance between commercial interests and public health.

What plans does Médecins Sans Frontières have in place to influence the TPP agreement?

MSF is working on several fronts to raise awareness about the dangerous provisions in the TPP that will hurt our patients, including speaking out and raising the issue in media, as with this interview.

Specifically, MSF is urging the U.S government to withdraw, and all other TPP governments to reject, harmful provisions that will hurt access to medicines. MSF is asking all TPP negotiators to insist on language that protects public health safeguards, fulfils existing international public health commitments, and enables countries to effectively balance commercial interests and public health. As noted above, MSF is also urging negotiators to increase transparency because we think that if more stakeholders with an interest in public health were able to look at the proposed text their proponents will be forced to improve it.

As TPP negotiators meet in Singapore this week for the sixteenth round of negotiations and under pressure to meet the announced October 2013 deadline, we are especially concerned because there has not been substantive discussion on access to medicines among TPP negotiators for over a year now. In March 2012 during the Australia round of negotiations, it is our understanding that many of the negotiating teams rejected the US draft chapter on intellectual property rights. While the U.S. government has stated that it would be resubmitting a revised chapter on this issue, they have not done so and access to medicines is once again not on the agenda this week in Singapore.

With the October 2013 deadline approaching, time is running out and these dangerous provisions could be shoe-horned into the final, precedent-setting agreement without adequate debate and public scrutiny.

We are asking the U.S. to end stall tactics on access to medicines and revise its proposals for what otherwise promises to be the most harmful trade deal ever for access to medicines in developing countries.

About Judit Rius

Judit Rius Sanjuan currently works as the US Manager of the Access Campaign for Doctors Without Borders/Médecins Sans Frontières (MSF) in New York. The MSF Access Campaign's purpose is to ensure greater access to, and the development of, life-saving and life prolonging medicines, diagnostic tests, and vaccines for patients.

Prior to joining the MSF Access Campaign, Judit worked at Knowledge Ecology International (KEI), providing technical assistance to developing countries on intellectual property law and in negotiations at the World Health Organization and the World Intellectual Property Organization.

In addition, Judit was an adjunct professor at Georgetown Law School where she co-taught a human rights fact-finding seminar on access to essential medicines in Central America.

Judit also worked in the legal departments of an international pharmaceutical company, an information technology consulting firm, and a software company.

Judit received a Licenciatura en Derecho (JD equivalent) from Pompeu Fabra University in Barcelona, Spain, and a Master's Degree in International Studies from Pompeu Fabra and Geneva Universities.

In January 2006, she graduated from Stanford Law School with an LLM in Law, Science, and Technology.

Comments

Malaysia has a policy that discriminates non-Malay, non-Muslim citizens. Licenses, loans, contracts, university quotas, opportunities and employment in the public and private sector are SPECIFIALLY reserved for the majority-Malay/Muslim population. So when the United States deals with Malaysia, they will be dealing with a category of people who empowered by racist policies in the guise of affirmative action.

How is it that the USA can condone racism, racial discrimination and offences against humanity when they deal with a country like Malaysia in the form of business-Non-Malay /Non-Muslim cannot obtain a license because of his color, religion and customs? This should not be the case-the USA and other nations should apply universal law and demand that all citizens in Malaysia be treated equally. Countries should not condone racist policies!

STReM stands for Super Time-Resolved Microscopy, and as STORM, PALM, and other methods are designed to improve spatial resolution of optical microscopy, we desire to improve the time resolution. STReM makes use of point spread function engineering to encode fast events into each camera frame.

Lisa G. Lawson has over 25 years’ experience in supporting large and small pharmaceutical companies in contamination control, including cleaning and disinfection strategies, aseptic manufacturing and use of risk-based approaches to microbiological quality challenges

Other Useful Links

News-Medical.Net provides this medical information service in accordance
with these terms and conditions.
Please note that medical information found
on this website is designed to support, not to replace the relationship
between patient and physician/doctor and the medical advice they may provide.